Using Lay Health Advisors to Improve Hypertension Management
Primary Purpose
Hypertension
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lay Health Advisor
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Community Health Workers, Community-Based Participatory Research, Health Equity
Eligibility Criteria
Inclusion Criteria:
- At least 2 outpatient blood pressures with systolic >140 or diastolic >90 mm Hg in last 6 months. Separate occurrences at least 1 day apart
- Age 18-59 years
- Non-diabetic
- Preserved kidney function (glomerular filtration rate >60 ml/min)
- English speaking
Exclusion Criteria:
- Mentally incompetent
- Pregnant
- Terminal illness
- Active substance abuse
- Documented coronary, peripheral arterial, or cerebrovascular disease
Sites / Locations
- The MetroHealth System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lay Health Advisors
Usual Care
Arm Description
Intervention patients will meet monthly in small groups with a trained Lay Health Advisor.
Control patients will receive usual care from their doctors.
Outcomes
Primary Outcome Measures
Change in systolic and diastolic blood pressure
Difference between final and initial systolic and diastolic blood pressure readings
Secondary Outcome Measures
Change in quality of life.
Differences in quality of life between final and initial measurements using the 12 item short form survey (SF-12). The SF-12 provides physical and mental health composite scores ranging from 0 (lowest level of health) to 100 (highest level of health)
Full Information
NCT ID
NCT03515005
First Posted
March 29, 2018
Last Updated
April 9, 2021
Sponsor
MetroHealth Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03515005
Brief Title
Using Lay Health Advisors to Improve Hypertension Management
Official Title
Using Lay Health Advisors to Help African Americans Address the Social Context of Hypertension Management
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrollment target not reached
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension.
Detailed Description
Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. Health providers generally lack the skills and resources to address social contextual factors (i.e. health and community services, social networks, social stressors, physical environment, and economic resources) that influence management of hypertension. Instead, providers tend to focus on adjusting antihypertensive medication prescriptions and exhorting patients to exercise and eat better. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension. Helping patients address these barriers may lead not only to improved blood pressure but also to increased survival, reduced organ damage, and decreased health care costs. This project may also serve as a model of healthcare delivery innovation that could be used to address other health disparity conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Community Health Workers, Community-Based Participatory Research, Health Equity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lay Health Advisors
Arm Type
Experimental
Arm Description
Intervention patients will meet monthly in small groups with a trained Lay Health Advisor.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Control patients will receive usual care from their doctors.
Intervention Type
Behavioral
Intervention Name(s)
Lay Health Advisor
Intervention Description
Patients will meet regularly Lay Health Advisors who will address the social context of their hypertension.
Primary Outcome Measure Information:
Title
Change in systolic and diastolic blood pressure
Description
Difference between final and initial systolic and diastolic blood pressure readings
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in quality of life.
Description
Differences in quality of life between final and initial measurements using the 12 item short form survey (SF-12). The SF-12 provides physical and mental health composite scores ranging from 0 (lowest level of health) to 100 (highest level of health)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 2 outpatient blood pressures with systolic >140 or diastolic >90 mm Hg in last 6 months. Separate occurrences at least 1 day apart
Age 18-59 years
Non-diabetic
Preserved kidney function (glomerular filtration rate >60 ml/min)
English speaking
Exclusion Criteria:
Mentally incompetent
Pregnant
Terminal illness
Active substance abuse
Documented coronary, peripheral arterial, or cerebrovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Thornton, MD, MPH
Organizational Affiliation
The MetroHealth System
Official's Role
Principal Investigator
Facility Information:
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Using Lay Health Advisors to Improve Hypertension Management
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